NCT02185443RecruitingPhase 2
Stereotactic Body Radiation Therapy (SBRT) for Unresectable Liver Metastases
Stereotactic Body Radiation Therapy for the Treatment of Unresectable Liver Metastases in Patients With Colorectal Adenocarcinoma, Carcinoma of the Anal Canal and Gastrointestinal Neuroendocrine Tumors
Source: ClinicalTrials.gov · Last updated 9 Dec 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
This is a Phase II study to determine the efficacy of SBRT to treat liver metastases in patients with Colorectal Adenocarcinoma, Carcinoma of the Anal Canal and Gastrointestinal Neuroendocrine Tumors that are not amenable to surgery. Patients should have no evidence of extra-hepatic disease or have disease that is planned to be treated with curative intent. Therefore, SBRT is being considered as a potentially curative procedure.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 43 (estimated)
- First submitted
- 4 Jul 2014
- Start date
- 1 May 2014
- Primary completion date
- 31 Dec 2026
- Lead sponsor
- University of Sao Paulo
- Diseases
- Neuroendocrine tumours, Colorectal cancer
- NCT number
- NCT02185443
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 43
- From 1 May 2014 to the primary completion date, 31 Dec 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Concomitant chemotherapy
- Prior radiotherapy to the upper abdomen
Other illness
- Active hepatitis or clinically significant liver failure
- Prior invasive neoplasm except for non-melanoma skin cancer, or unless more than five years without evidence of disease
Other
- Pregnancy
- Underlying Cirrhosis
- Severe Comorbidity
- Current anticoagulant treatment
Who the study is looking for
- Karnofsky Performance Scale (KPS) equal or greater than 70
- 1 to 4 liver metastases with an individual maximum diameter of up to 5 cm
- Lesions considered unresectable or patients considered unfit for surgery
- Histology of the primary tumor: colorectal adenocarcinoma, carcinoma of the anal canal or gastrointestinal neuroendocrine tumors.
- Absence of evidence of extra-hepatic disease or extra-hepatic disease to be treated with curative intent.
- Minimum interval of 2 weeks between systemic chemotherapy and SBRT.
- Adequate bone marrow function defined as:
- absolute neutrophils count \> 1,800 cells / mm 3
- platelets \> 100,000 cells / mm 3
- hemoglobin \> 8.0 g / dl ( transfusion or other intervention accepted)
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Instituto do Câncer do Estado de São Paulo Coordinator of this site? Confirm its status | São Paulo | Brazil | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.